A Pilot Study of Shoulder Subluxation Treatment by Using the Self-Designed Surface Functional Electrical Stimulator

Stroke Clinical Trial

Official title:

Rehabilitation Robot for Upper Limbs, Component Project 2: Hybrid of FES and Rehabilitation Robot for Treatment of Shoulder Subluxation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01139034
• Other study ID #: 201002029D
• Status: Recruiting
• Phase: Phase 1
• First received: June 7, 2010
• Last updated: June 20, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Jin-Shin Lai
• Phone: +886-2-23123456
• Email: jslai[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of the self-designed surface functional electrical stimulator on shoulder joint subluxation for stroke patients

Description:

Functional electrical stimulation (FES) is a common and effective therapeutic approach for clinical treatments of shoulder subluxation. By applying low-frequency electrical stimulation to the target muscle groups, improvements may be observed in terms of muscle strength, subluxation, and passive humeral lateral rotation of the shoulder joint. In order to overcome issues regarding the integration of an FES and a rehabilitation robot, group members have designed a customized FES system approved by medical safety regulations. Despite sharing identical specifications with commercial models, the approved 2-channel FES system provides better integrity and control when working with the upper extremity rehabilitation robot. In this study, three patients with unilateral shoulder subluxation will be recruited. Limited shoulder x-ray photos shall be taken before, during, and after the FES shoulder subluxation treatment for studying the effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• stroke (1-3 months)

• Brunnstrom Stage I-III

• single, unilateral

Exclusion Criteria:

• aphasic

• shoulder impairment

• severe osteoporosis

• cardiac arrhythmias or having a pacemaker implanted

• abnormal cutaneous sensation at the target areas

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Self-designed surface functional electrical stimulator
Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upward migration index		1 year	No
Secondary	Acromiohumeral distance		1 year	No